Elevating Compliance Standards in Healthcare

At Altum Health Compliance, we are committed to enhancing the quality and regulatory standards within the clinical research and healthcare sectors. Our expert team collaborates with organizations to deliver strategic guidance, ensure GCP compliance, and prepare for audits, all while providing comprehensive quality solutions. With a foundation built on extensive industry experience and unwavering integrity, we empower sponsors, CROs, and clinical sites to confidently navigate the complexities of clinical operations, safeguarding patient welfare and ensuring data reliability throughout every development phase.

Features

Comprehensive Compliance Oversight

Our team provides thorough oversight of Good Clinical Practice (GCP) compliance, ensuring that your clinical trials meet the highest regulatory standards. We help you maintain audit readiness and navigate complex compliance landscapes with ease.

Strategic Guidance

We offer tailored strategic guidance to help organizations align their operations with regulatory requirements. Our expertise empowers sponsors, CROs, and clinical sites to make informed decisions that enhance quality and efficiency.

End-to-End Quality Solutions

From initial planning to final reporting, our end-to-end quality solutions ensure that every phase of your clinical operations is ethical, efficient, and inspection-ready. We are committed to protecting patient safety and data integrity.

Industry Expertise

With deep industry experience, our team is dedicated to elevating quality and regulatory standards. We understand the complexities of clinical research and healthcare, providing you with the confidence to navigate challenges effectively.

About Altum Health Compliance

At Altum Health Compliance LLC, we are committed to enhancing quality and regulatory standards within the clinical research and healthcare sectors. Our mission is to partner with organizations to deliver strategic guidance, ensure GCP compliance oversight, and prepare for audits with confidence. We provide comprehensive quality solutions that promote ethical, efficient, and inspection-ready clinical operations. With a foundation built on extensive industry experience and unwavering integrity, Altum empowers sponsors, CROs, and clinical sites to navigate the complexities of clinical development, safeguarding patient welfare and ensuring the reliability of data at every stage.

Latest Regulations

Good Clinical Practice (GCP) guidelines, ICH E6(R3)

Finalized January 2025


Latest in GCP Compliance: ICH E6(R3) Now Finalized

As of January 2025, the International Council for Harmonisation (ICH) has finalized the updated Good Clinical Practice guideline: ICH E6(R3). This modernized standard reflects the evolving landscape of clinical research and emphasizes data integrity, patient-centricity, and risk-based quality management.

Key Updates to Know:

  • Quality by Design: Trials must now proactively identify and manage risks that impact data integrity and participant safety. This approach improves trial design and efficiency.
  • Data Integrity & Governance: With the rise of digital trials, E6(R3) prioritizes robust data management throughout the lifecycle of a study, including security and traceability.
  • Support for Decentralized & Adaptive Trials: E6(R3) accommodates innovation in trial design, encouraging the use of eConsent, remote monitoring, and digital platforms.
  • Participant Communication: Transparency is a key principle. Sponsors must now ensure trial results are shared with participants in accessible, non-technical language.


Why This Matters:

Clinical research sites, sponsors, and CROs must align with these standards to remain compliant, competitive, and ethically sound.


At Altum Health Compliance, we help you:

  • Implement risk-based quality systems
  • Modernize your SOPs and inspection-readiness plans
  • Ensure your trial data meets the highest standards of integrity
  • Stay aligned with evolving global regulations


Stay compliant. Stay ahead.

Ready to bring your research operations up to E6(R3) standards?



Contact us today to learn how we can support your site or study.

Learn more
Let's talk!

Business Hours

Mon - Fri
-
Sat - Sun
Closed

Contact Us